How to Maximize Randomization and Trial Management Systems in Clinical Studies

Francesco Spoto, Clinical Study Expert, highlights the advantages of using IRT solutions for pharma's SMEs and the best strategies to reap its benefits

Running a clinical trial is getting increasingly complex and costly, regardless of the size of the company.

While carrying out a study in the pharma development environment follows a standardized path both in terms of requirements and deliverables, the specificities of this exercise can differ dramatically depending on the availability of budget and human labor.

This article aims at assessing the best solution for small to medium enterprises (SMEs) to achieve clinical operations excellence. The focus highlights how Randomization and Trial Management Systems (RTMS), and Interactive Response Technology (IRT) platforms are best suited to ensure flexibility and control of trial operations while minimizing the administrative burden.

IRT systems have a greater efficiency in running a clinical program in a SME than alternative solutions, which include old-style excel and state-of-art Electronic Data Capture (EDC).

IRT has several competitive advantages over its competitors on clinical operations, supply chain management and end user experience. The following picture summarizes the main pros for clinical operational activities:

Benefits of IRT not Limited to Clinical Operations

Primarily, IRT makes the oversight of trial execution easy and streamlined, with quick setup and implementation of changes post go-live. It also supports the compliance with regulatory requirements, for both study design and patient safety.

Let us take a blinded randomized study as an example: IRT would allow a quick and clear setup of the randomization algorithm to eliminate selection bias, limit allocation concealment and ensure a correct balance among treatment. Furthermore, it enables all authorized users to track patient status and unblind an individual remotely, if appropriate, adding an additional layer of control in supporting patients following an adverse event. For SMEs, the latter also implies another competitive advantage in decreased labor intensity for site management (i.e.: less need of travelling to remote sites).

The benefits of IRT are not limited to clinical operations, but positively affect supply chain management too, especially for SMEs.

The Planning Phase is Critical

The worst potential outcome of a trial is failing to deliver the right results. Sometimes the same can be especially detrimental to a pharma SME, which may have tight timelines and tiny budgets to meet.

In order to avoid a trial burst, the planning phase is the most important with the supply forecast indeed being the most delicate step. IRT enables a study forecast with a data-based approach: the calculation is performed within the same IRT solution and can be based on treatment groups, balancing among treatments, risk criteria, and on similar past scenarios (i.e.: historical performance of site).

Once the initial forecast is completed, IRT supports an SME in closely managing the Investigational Products along the supply chain, from production to site delivery. Additionally, it enables greater flexibility in reacting to potential issues, such as delays at customs, temperature excursions, and slower or faster-than-expected recruitment rates.

The flexibility allows avoiding slowing down trial execution due to unexpected site stock-out. Furthermore it helps in minimizing IP wastage by refocusing on high-recruiting location and enabling fast relabeling hence reducing labor intensity in the overall supply management.

SMEs can benefit also from the availability of clear metrics and key performance indicators to improve their internal processes further.

Last but not least, let’s take a look at the impact of IRT to the end-user:

Providing Useful Guidance to Sites

Investigators and organizations can leverage a reliable system, ubiquitous data access and a clear drug return and accountability process to make site operations more effective. Every IRT solution guarantees a high level of service and expertise, available 24/7 via a helpdesk, to ensure a fast resolution of issues and provide useful guidance to sites.

To conclude, IRT solutions have great potential to drive success of SMEs in running clinical trials. They enable a fast, accurate, flexible and simplified way of managing a study by focusing on clinical operations, supply chain and site process streamlining.

However, SMEs’ success in using IRT solutions is heavily dependent on the implementation strategy. Leveraging the vendor’s expertise is strongly suggested for a naive team, which may be consulted to start using pre-coded packages with limited customization, reduced costs and fast delivery time, before moving to more complex solutions.

Having said all of that, a deep knowledge of both clinical processes and IRT technology, fitness to the overall business goal, and the right partner selection are of paramount importance in ensuring the enterprise reaps the technological benefits in full.